Takeda’s Entyvio (Vedolizumab), the World’s Only Gut-Selective Anti-Inflammatory Biologic, Demonstrates Long-Term Efficacy with Subcutaneous Formulation; Intravenous Form Approved in China

October 13, 2020 /BioValleyBIOON/ -- Takeda Pharmaceutical Company Limited (Takeda Pharma) recently at the 28th United European Gastroenterology Week (UEG Week 2020) virtualConferenceLong-term safety and efficacy data from the VISIBLE open-label extension (OLE) study of subcutaneous (SC) Entyvio® (vedolizumab), a gut-selective biologic, for maintenance therapy in patients with moderately to severely active ulcerative colitis (UC) were published.

In the evaluation of the primary safety endpoint of the trial, interim data from the UC patient population showed that long-term safety findings after 2 years of Entyvio SC maintenance therapy were consistent with the known safety profile of Entyvio. Furthermore, Entyvio SC treatment continued to demonstrate clinical benefits as assessed by clinical remission and steroid-free clinical remission.

VISIBLE OLE is an ongoing, open-label, multinational, multicenter Phase 3b study designed to evaluate the long-term safety and tolerability of Entyvio SC in adult patients with ulcerative colitis (UC) or Crohn’s disease (CD) who were enrolled in and participated in the VISIBLE 1 (UC) or VISIBLE 2 (CD) studies. Patients who completed the maintenance period through Week 52 (randomized completers) and those who received a third dose of intravenous Entyvio at Week 6 and achieved clinical response at Week 14 (non-randomized Week 14 responders) received treatment with Entyvio SC 108 mg every other week.

Interim data from the UC patient population in the VISIBLE OLE study showed that adverse events were consistent with the known safety profile of Entyvio. During the 2-year maintenance treatment period, 69% of UC patients experienced adverse events, with the most common being disease exacerbation (18%), nasopharyngitis (11%), and upper respiratory tract infection (9%).Anemia(7%). Injection site reactions were reported in 4.5% of patients, all of which were mild or moderate in severity. Serious adverse events occurred in 14% of patients, with no cases of progressive multifocal leukoencephalopathy and no deaths.

Among randomized completers, clinical remission rates and corticosteroid-free clinical remission rates were maintained through Week 108: the clinical remission rate was 71.0% (n=49/69) at Week 6 and 68.9% (n=42/61) at Week 108; the corticosteroid-free clinical remission rate was 78.3% (n=18/23) at Week 52 and 70.0% (n=14/20) at Week 108. Among non-randomized Week 14 responders, the clinical remission rate was 62.6% (n=67/107) at Week 14 and 33.3% (n=31/93) at Week 110; the corticosteroid-free clinical remission rate was 24.5% (n=12/49) at Week 54 and 25.0% (n=11/44) at Week 110.。

Dr. Asit Parikh, Head of Takeda’s Gastroenterology Therapeutic Area, stated, “These latest safety and efficacy data for Entyvio SC provide additional support that the benefits of subcutaneous Entyvio are sustained during long-term maintenance therapy. Entyvio SC was approved in the European Union in May 2020, offering more administration options to accommodate patients’ diverse medical needs and preferences, including the option for home administration outside of healthcare settings. Takeda remains committed to innovation in gastroenterology, and we are working on developing a needle-free jet injector to further expand patient choices.”

Two Common Types of Inflammatory Bowel Disease (IBD) (Image source: tsukuba.ac.jp)

Entyvio is a gut-selective biologic agent. Its active pharmaceutical ingredient, vedolizumab, is a fully humanized monoclonal antibody that specifically antagonizes α4β7 integrin, thereby inhibiting the binding of α4β7 integrin to the gut mucosal cell adhesion molecule MAdCAM-1. MAdCAM-1 is selectively expressed in the gastrointestinal vasculature and lymph nodes. α4β7 integrin is expressed on a subset of circulating leukocytes, which have been demonstrated to play a critical role in mediating inflammation in Crohn’s disease (CD) and ulcerative colitis (UC).

Entyvio intravenous (IV) formulation was approved for marketing in the United States and the European Union in May 2014, for the treatment of patients who have had an inadequate response to conventional therapy orTumorAdult patients with moderate to severe active ulcerative colitis (UC) and Crohn’s disease (CD) who have had an inadequate response to tumor necrosis factor alpha (TNFα) antagonists. Currently, the intravenous (IV) formulation of Entyvio is marketed in 71 countries worldwide. UC and CD are the two most common forms of inflammatory bowel disease (IBD).

In May this year, the subcutaneous (SC) formulation of Entyvio received approval from the European Commission (EC) as a maintenance therapy for adult patients with moderate-to-severe ulcerative colitis (UC) and Crohn’s disease (CD). The Entyvio SC product includes pre-filled syringes and pre-filled injection pens. Notably, Entyvio is the only maintenance therapy approved for adult patients with UC and CD that offers both intravenous (IV) and subcutaneous (SC) formulations, thereby providing patients with more treatment options.

In China, Entyvio IV (Entyvio®, vedolizumab, vedolizumab for injection) was approved in March this year for adult patients with moderately to severely active ulcerative colitis (UC) and Crohn’s disease (CD) who have had an inadequate response, lost response, or intolerance to conventional therapy or TNFα inhibitors. Entyvio (Entyvio®) was included in the first batch of the List of Overseas New Drugs in Urgent Clinical Need, thereby qualifying for expedited review.

Entyvio® (vedolizumab) is currently the only gut-selective biologic agent in the field of inflammatory bowel disease (IBD). Clinical data demonstrate its rapid onset of action, achievement of sustained long-term clinical remission and mucosal healing, and favorable safety profile. It is recommended as a first-line biologic therapy by international guidelines in Europe and the United States.

From the inclusion of Entyvio® (vedolizumab for injection) in the first batch of overseas new drugs urgently needed for clinical use to its rapid approval, this fully demonstrates the Chinese government's determination to accelerate the introduction of innovative drugs and continuously improve people's health and quality of life. The approval and launch of this drug in China will provide a new treatment option for the vast number of patients with moderate-to-severe IBD in China. (Bioon.com)

Original Source: Safety and Efficacy of Subcutaneous Entyvio® (Vedolizumab) Sustained During Long-term Maintenance Therapy in Adults with Moderately to Severely Active Ulcerative Colitis